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    R&D Business Operations Manager - Raleigh, United States - Merz North America

    Merz North America
    Merz North America Raleigh, United States

    3 weeks ago

    Default job background
    Description

    Reporting to the Head of R&D Business Operations this role will work with the Head of R&D Business Operations to execute the R&D strategy related to driving R&D operational excellence.

    The incumbent will work with the Head of R&D Business Operations to manage the overall planning, execution, and delivery of key R&D initiatives that support the overall R&D goals. This will include being the R&D Training Lead and R&D Archivist (paper). You will lead cross-functional R&D continuous improvement to enhance R&D effectiveness. You will partner with other internal departments in cross-department projects and represent R&D with external vendors.

    Essential Duties and Responsibilities

    • R&D Training Lead: Owner of the R&D Training platform and associated processes including (but not limited to):
      • Develop and manage a consistent and comprehensive R&D interview and onboarding process
      • Develop an R&D training platform to include functional- and project-related training for both internal and external team members
      • Own the R&D Training SOP and associated forms and training matrix
      • Be the R&D Inspection and Audit Training SME to include the retrieval of training records for employees
      • Develop & implement R&D GxP refresher regulatory compliance training
      • Manage and report on training compliance metrics
      • Manage R&D staff training inquiries
      • Facilitate R&D lunch and learn series
    • R&D Archivist (paper): Manage the R&D paper archiving process and vendors. Assist in sending/retrieving paper from archives in a timely manner:
      • Maintain a collaborative relationship with off-site vendor archive contacts
      • R&D Liaison manage scheduling of pick-up and deliveries to the facility working with R&D functional SMEs responsible study for document management
      • Manage scheduling of pick-up and deliveries to the facility, monitor associated costs make recommendations to Management regarding the vendor relationship
    • Graduate / Internship Program: Assist the Head of R&D Business Operations to manage the R&D graduate/internship program:
      • Support Head of Business Operations by fostering & maintaining collaboration with academic institutions
      • Coordinating with R&D functions to assign projects, and ensuring the program aligns with the R&D department objectives
      • Oversee Graduate/Intern onboarding and training. This includes providing guidance, assigning mentors, and facilitating onboarding or training sessions
      • Serve as a liaison between the graduate/intern program participants and the R&D functional teams. Facilitating communication, coordinating project assignments, and ensuring a productive working environment for both parties
      • Oversee Graduate/Intern off-boarding program metrics including, gathering feedback from program participants, tracking functional team feedback, and incorporating innovative approaches to make the program more impactful
    • Vendor & Contract Management: Work with the Head of R&D Business Operations to enhance vendor selection, management and oversight including the establishment of preferred vendors.
    Job Related Qualifications/Skills

    Professional Experience
    • Required:
      • Extensive knowledge of ICH GCP and ISO
      • Device/Pharmaceutical background
    • Preferred:
      • Stakeholder facilitation and management
    Knowledge, Skills, and Abilities
    • Required:
      • Excellent interpersonal skills
      • First-class organizational skills
      • Excellent MS Office skills
      • Proven success in training, archiving and process improvement
      • Proactive approach to work; demonstrates initiative and reliability
      • High standard of written and spoken English
    • Preferred:
      • Excellent negotiation skills
    Education
    • Required:
      • Strong process improvement background e.g., Lean Six Sigma Certification
    • Preferred:
      • Life sciences degree-level qualification
    Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

    The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)
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